(32 days)
No
The summary describes a standard ultrasound system with various imaging modes and post-processing capabilities, but there is no mention of AI, ML, or related concepts like deep learning or neural networks. The sections on training and test sets are marked as "Not Applicable," which would typically be included for AI/ML devices.
No
The device is described as a "Diagnostic Ultrasound System" and its intended use is to "acquire and display ultrasound images" for exams, which indicates a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "Diagnostic Ultrasound System" and is "intended for use in fetal, abdominal, pediatric, small organ... exams." Additionally, "Device Description" also labels it as an "ultrasound diagnostic system."
No
The device description explicitly states it is a "general purpose, mobile, software controlled, ultrasound diagnostic system" and mentions employing "an array of probes," which are hardware components. The performance studies also include testing for hardware-related standards like electrical safety and acoustic output.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this is a "Diagnostic Ultrasound System." Its function is to "acquire and display ultrasound images" of internal anatomical structures and fluid flow within the body.
- Input Modality: The input modality is Ultrasound, which is an imaging technique applied externally or internally to the body, not a method of analyzing samples taken from the body.
- No Mention of Sample Analysis: There is no mention of analyzing biological samples or performing tests on them.
Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
DC-90/DC-90S/DC-900/DC-95/DC-95S/DC-88/DC-80A/DC-80A Exp/DC-80A Pro/DC-80A Pro/DC-8X/DC-80/DC-80/DC-80/DC-80/DC-81/ DC-82 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatic, small organ(breast, thyroid, testes), neonatal and adult cephalic, transrectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediative cardiac, peripheral vessel and urology exams.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, LLZ
Device Description
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CW mode, Color-mode, Color M-mode, Power/Dirpower mode, TDI mode, THI, iScape, Biopsy Guidance, 3D/4D mode, Elastography, Contrast imaging or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel, urology
Indicated Patient Age Range
adults, pregnant women, pediatric patients and neonates.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed and found to conform with applicable medical safety standards, including software, cybersecurity testing, acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety. Clinical tests were Not Applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 8, 2019 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Zhang Wei Engineer of Technical Regulation Keji 12th Road South, Hi-tech Industrial Park Shenzhen, Guangdong 518057 CHINA Re: K190206 Trade/Device Name: DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/ DC-80A/DC/80A Exp/DC-80A Pro/DC-8X/DC-80/DC-81/DC82 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, LLZ Dated: January 25, 2019 Received: February 4, 2019
Dear Zhang Wei:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jeff Rogge
for Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
DC-90/DC-90S/DC-900/DC-95/DC-95/DC-88/DC-888/DC-80A/DC-80A Pro/DC-80A Pro/DC-80/DC-80/DC-81/DC-81/DC-81 Diagnostic Ultrasound System
Indications for Use (Describe)
DC-90/DC-90S/DC-900/DC-95/DC-95S/DC-88/DC-80A/DC-80A Exp/DC-80A Pro/DC-80A Pro/DC-8X/DC-80/DC-80/DC-80/DC-80/DC-81/ DC-82 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatic, small organ(breast, thyroid, testes), neonatal and adult cephalic, transrectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediative cardiac, peripheral vessel and urology exams.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| System: | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Transducer: | N/A | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| General (Track | |||||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (specify) | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal Imaging | |||||||||||
| & Other | Fetal | N | N | N | N | N | N | Note 1, 2,3, 4, 6, 7 | |||
| Abdominal | N | N | N | N | N | N | N | Note 1, 2,3, | |||
| 4,6,7,9,11,12 | |||||||||||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Small Organ (Specify**) | N | N | N | N | N | N | N | Note 1,2, 4,7,8,11,12 | |||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Adult Cephalic | N | N | N | N | N | N | N | Note 1,2,4,6,7 | |||
| Trans-rectal | N | N | N | N | N | N | N | Note 1, 2,3, 4, 6, 7, 8 | |||
| Trans-vaginal | N | N | N | N | N | N | N | Note 1, 2,3, 4, 6, 7, 8 | |||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | N | N | N | N | N | N | Note 1, 2, | ||||
| 4,6,7,8,11,12 | |||||||||||
| Musculo-skeletal | |||||||||||
| (Superficial) | N | N | N | N | N | N | Note 1, 2, 4,7,8,11,12 | ||||
| Intravascular | |||||||||||
| Cardiac Adult | N | N | N | N | N | N | N | Note 1, 2,4,5,6,7,10 | |||
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,5,6,7 | |||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral | |||||||||||
| vessel | Peripheral vessel | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Other (Specify***) | N | N | N | N | N | N | Note 1, 2, 4, 6, 7,8 | ||||
| N=new indication; P=previously cleared by FDA; | E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B. | |||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular | |||||||||||
| ** Small organ-breast, thyroid, testes. | |||||||||||
| ***Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |||||||||||
| Note 2: Smart3D | |||||||||||
| Note 3:4D(Real-time 3D) | |||||||||||
| Note 4: iScape | |||||||||||
| Note 5: TDI | |||||||||||
| Note 6: Color M | |||||||||||
| Note 7: Biopsy Guidance | |||||||||||
| Note 8: Strain Elastography | |||||||||||
| Note 9: Contrast imaging (Contrast agent for Liver) | |||||||||||
| Note 10: Contrast imaging(contrast agent for LVO) | |||||||||||
| Note 11: STE | |||||||||||
| Note 12: STQ | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | |||||||||||
| Prescription USE (Per 21 CFR 801.109) | |||||||||||
| System: | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- | ||||||||||
| 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | |||||||||||
| Transducer: | C11-3E | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | |||||||||||
| Mode of Operation | |||||||||||
| General (Track | |||||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (specify) | ||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Small Organ (Specify**) | |||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Fetal Imaging | |||||||||||
| & Other | Adult Cephalic | ||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Superficial) | |||||||||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral | |||||||||||
| vessel | Peripheral vessel | ||||||||||
| Other (Specify***) | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B. | |||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | |||||||||||
| **Small organ-breast, thyroid, testes. | |||||||||||
| ***Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |||||||||||
| Note 2: Smart3D | |||||||||||
| Note 3:4D(Real-time 3D) | |||||||||||
| Note 4: iScape | |||||||||||
| Note 5: TDI | |||||||||||
| Note 6: Color M | |||||||||||
| Note 7: Biopsy Guidance | |||||||||||
| Note 8: Elastography | |||||||||||
| Note 9: Contrast imaging (Contrast agent for Liver) | |||||||||||
| Note 10: Contrast imaging(contrast agent for LVO) | |||||||||||
| Note 11: STE | |||||||||||
| Note 12: STQ | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | |||||||||||
| Prescription USE (Per 21 CFR 801.109) | |||||||||||
| System: | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- | ||||||||||
| 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | |||||||||||
| Transducer: | L12-3E | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| General (Track | |||||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (specify) | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | |||||||||||
| Abdominal | N | N | N | N | N | N | Note 1, 2, 4,7 | ||||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | N | N | N | N | N | N | Note 1, 2, 4,7 | ||||
| Small Organ (Specify**) | N | N | N | N | N | N | Note 1,2, 4,7,8,11,12 | ||||
| Neonatal Cephalic | |||||||||||
| Fetal Imaging | |||||||||||
| & Other | Adult Cephalic | ||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | N | N | N | N | N | N | Note 1, 2, 4,7,11,12 | ||||
| Musculo-skeletal | |||||||||||
| (Superficial) | N | N | N | N | N | N | Note 1, 2, 4,7,11,12 | ||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral | |||||||||||
| vessel | Peripheral vessel | N | N | N | N | N | N | Note 1, 2, 4,7 | |||
| Other (Specify***) | |||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B. | |||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | |||||||||||
| **Small organ-breast, thyroid, testes. | |||||||||||
| ***Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |||||||||||
| Note 2: Smart3D | |||||||||||
| Note 3:4D(Real-time 3D) | |||||||||||
| Note 4: iScape | |||||||||||
| Note 5: TDI | |||||||||||
| Note 6: Color M | |||||||||||
| Note 7: Biopsy Guidance | |||||||||||
| Note 8: Elastography | |||||||||||
| Note 9: Contrast imaging (Contrast agent for Liver) | |||||||||||
| Note 10: Contrast imaging(contrast agent for LVO) | |||||||||||
| Note 11: STE | |||||||||||
| Note 12: STQ | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | |||||||||||
| Prescription USE (Per 21 CFR 801.109) | |||||||||||
| System: | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- | ||||||||||
| 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | |||||||||||
| Transducer: | P7-3E | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | |||||||||||
| Mode of Operation | |||||||||||
| General (Track | |||||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (specify) | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | |||||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1,2,4,6 | |||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1,2,4,6 | |||
| Small Organ (Specify**) | |||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,2,4,6 | |||
| Fetal Imaging | |||||||||||
| & Other | Adult Cephalic | N | N | N | N | N | N | N | Note 1,2,4,6 | ||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Superficial) | |||||||||||
| Intravascular | |||||||||||
| Cardiac Adult | N | N | N | N | N | N | N | Note 1, 2,4,5,6 | |||
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2,4,5,6 | |||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral | |||||||||||
| vessel | Peripheral vessel | ||||||||||
| Other (Specify***) | |||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||||
| Additional comments: Combined modes--B+M\u3001PW+B\u3001Color + B\u3001Power+B\u3001PW+Color+B\u3001Power+PW+B. | |||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | |||||||||||
| **Small organ-breast, thyroid, testes. | |||||||||||
| ***Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |||||||||||
| Note 2: Smart3D | |||||||||||
| Note 3:4D(Real-time 3D) | |||||||||||
| Note 4: iScape | |||||||||||
| Note 5: TDI | |||||||||||
| Note 6: Color M | |||||||||||
| Note 7: Biopsy Guidance | |||||||||||
| Note 8: Elastography | |||||||||||
| Note 9: Contrast imaging (Contrast agent for Liver) | |||||||||||
| Note 10: Contrast imaging(contrast agent for LVO) | |||||||||||
| Note 11: STE | |||||||||||
| Note 12: STQ | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | |||||||||||
| Prescription USE (Per 21 CFR 801.109) | |||||||||||
| System: | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | ||||||||||
| Transducer: | L9-3E | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| General (Track 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (Specify) | ||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | |||||||||||
| Abdominal | N | N | N | N | N | N | Note 1,2, 4,7 | ||||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | N | N | N | N | N | N | Note 1,2, 4,7 | ||||
| Small Organ (Specify**) | N | N | N | N | N | N | Note 1,2, 4,7,8,11,12 | ||||
| Neonatal Cephalic | |||||||||||
| Fetal Imaging | |||||||||||
| & Other | Adult Cephalic | ||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | N | N | N | N | N | N | Note 1,2, 4,7,11,12 | ||||
| Musculo-skeletal | |||||||||||
| (Superficial) | N | N | N | N | N | N | Note 1,2, 4,7,11,12 | ||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral | |||||||||||
| vessel | Peripheral vessel | N | N | N | N | N | N | Note 1,2, 4,7 | |||
| Other (Specify***) | |||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B. | |||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular | |||||||||||
| **Small organ-breast, thyroid, testes, | |||||||||||
| ***Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||||
| Note 2: Smart3D | |||||||||||
| Note 3:4D(Real-time 3D) | |||||||||||
| Note 4: iScape | |||||||||||
| Note 5: TDI | |||||||||||
| Note 6: Color M | |||||||||||
| Note 7: Biopsy Guidance | |||||||||||
| Note 8: Elastography | |||||||||||
| Note 9: Contrast imaging (Contrast agent for Liver) | |||||||||||
| Note 10: Contrast imaging(contrast agent for LVO) | |||||||||||
| Note 11: STE | |||||||||||
| Note 12: STQ | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | |||||||||||
| Prescription USE (Per 21 CFR 801.109) | |||||||||||
| System: | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | ||||||||||
| Transducer: | DE11-3E | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | General (Track 1 Only) | Specific (Track 1 & 3) | Mode of Operation | Other (Specify) | |||||||
| B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | |||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal Imaging & Other | Fetal | N | N | N | N | N | N | N | Note 1, 3, 4, 6, 7 | ||
| Abdominal | |||||||||||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify**) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Trans-rectal | N | N | N | N | N | N | N | Note 1, 3, 4, 6, 7, 8 | |||
| Trans-vaginal | N | N | N | N | N | N | N | Note 1, 3, 4, 6, 7, 8 | |||
| Trans-urethral | |||||||||||
| Cardiac | Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal (Conventional) | |||||||||||
| Musculo-skeletal (Superficial) | |||||||||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Intravascular (Cardiac) | |||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral vessel | Peripheral vessel | ||||||||||
| Other (Specify***) | |||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B. | |||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | |||||||||||
| **Small organ-breast, thyroid, testes. | |||||||||||
| ***Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||||
| Note 2: Smart3D | |||||||||||
| Note 3:4D(Real-time 3D) | |||||||||||
| Note 4: iScape | |||||||||||
| Note 5: TDI | |||||||||||
| Note 6: Color M | |||||||||||
| Note 7: Biopsy Guidance | |||||||||||
| Note 8: Elastography | |||||||||||
| Note 9: Contrast imaging (Contrast agent for Liver) | |||||||||||
| Note 10: Contrast imaging(contrast agent for LVO) | |||||||||||
| Note 11: STE | |||||||||||
| Note 12: STQ | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | |||||||||||
| System: | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- | ||||||||||
| 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | |||||||||||
| Transducer: | V11-3HE | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| General (Track | |||||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (Specify) | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | N | N | N | N | N | N | Note 1, 2, 4, 6, 7 | ||||
| Abdominal | |||||||||||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify**) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Fetal Imaging | |||||||||||
| & Other | Adult Cephalic | ||||||||||
| Trans-rectal | N | N | N | N | N | N | Note 1, 2, 4, 6, 7, 8 | ||||
| Trans-vaginal | N | N | N | N | N | N | Note 1, 2, 4, 6, 7, 8 | ||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Superficial) | |||||||||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral | |||||||||||
| vessel | Peripheral vessel | ||||||||||
| Other (Specify***) | N | N | N | N | N | N | Note 1, 2, 4, 6, 7, 8 | ||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B. | |||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | |||||||||||
| **Small organ-breast, thyroid, testes. | |||||||||||
| ***Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||||
| Note 2: Smart3D | |||||||||||
| Note 3:4D(Real-time 3D) | |||||||||||
| Note 4: iScape | |||||||||||
| Note 5: TDI | |||||||||||
| Note 6: Color M | |||||||||||
| Note 7: Biopsy Guidance | |||||||||||
| Note 8: Elastography | |||||||||||
| Note 9: Contrast imaging (Contrast agent for Liver) | |||||||||||
| Note 10: Contrast imaging(contrast agent for LVO) | |||||||||||
| Note 11: STE | |||||||||||
| Note 12: STQ | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | |||||||||||
| Prescription USE (Per 21 CFR 801.109) | |||||||||||
| System: | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- | ||||||||||
| 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | |||||||||||
| Transducer: | SP5-1E | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| General (Track | |||||||||||
| 1 Only) | Clinical Application | ||||||||||
| Specific (Track 1 & 3) | Mode of Operation | ||||||||||
| B | M | PWD | CWD | Color | |||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (specify) | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal Imaging | |||||||||||
| & Other | Fetal | ||||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1, 2,4, 6,7 | |||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2,4, 6,7 | |||
| Small Organ (Specify**) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2,4, 6,7 | |||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Superficial) | |||||||||||
| Intravascular | |||||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | Note 1, 2,4,5,6,7,10 | ||
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2,4,5,6,7 | |||
| Intravascular (Cardiac) | |||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral | |||||||||||
| vessel | Peripheral vessel | ||||||||||
| Other (Specify***) | |||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B. | |||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | |||||||||||
| **Small organ-breast, thyroid, testes. | |||||||||||
| ***Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |||||||||||
| Note 2: Smart3D | |||||||||||
| Note 3:4D(Real-time 3D) | |||||||||||
| Note 4: iScape | |||||||||||
| Note 5: TDI | |||||||||||
| Note 6: Color M | |||||||||||
| Note 7: Biopsy Guidance | |||||||||||
| Note 8: Elastography | |||||||||||
| Note 9: Contrast imaging (Contrast agent for Liver) | |||||||||||
| Note 10: Contrast imaging(contrast agent for LVO) | |||||||||||
| Note 11: STE | |||||||||||
| Note 12: STQ | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | |||||||||||
| Prescription USE (Per 21 CFR 801.109) | |||||||||||
| System: | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | ||||||||||
| Transducer: | SC6-1E | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (Specify) | ||||||||||
| General (Track | |||||||||||
| 1 Only) | Specific (Track 1 & 3) | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | N | N | N | N | N | N | N | Note 1, 2, 4, 6,7 | |||
| Abdominal | N | N | N | N | N | N | N | Note 1, 2, | |||
| 4,6,7,9,11,12 | |||||||||||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify**) | |||||||||||
| Fetal Imaging | |||||||||||
| & Other | Neonatal Cephalic | ||||||||||
| Adult Cephalic | |||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Musculo-skeletal | |||||||||||
| (Superficial) | |||||||||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral | |||||||||||
| vessel | Peripheral vessel | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | ||
| Other (Specify***) | |||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B. | |||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | |||||||||||
| **Small organ-breast, thyroid, testes. | |||||||||||
| ***Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging | |||||||||||
| Note 2: Smart3D | |||||||||||
| Note 3:4D(Real-time 3D) | |||||||||||
| Note 4: iScape | |||||||||||
| Note 5: TDI | |||||||||||
| Note 6: Color M | |||||||||||
| Note 7: Biopsy Guidance | |||||||||||
| Note 8: Elastography | |||||||||||
| Note 9: Contrast imaging (Contrast agent for Liver) | |||||||||||
| Note 10: Contrast imaging(contrast agent for LVO) | |||||||||||
| Note 11: STE | |||||||||||
| Note 12: STQ | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | |||||||||||
| Prescription USE (Per 21 CFR 801.109) | |||||||||||
| System: | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | ||||||||||
| Transducer: | SD8-1E | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| General (Track | |||||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (Specify) | ||||||||||
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | N | N | Note 1, 3, 4, 6,7 | |||
| Abdominal | N | N | N | N | N | N | N | Note 1, 3, 4,6,7 | |||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify**) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Fetal Imaging | |||||||||||
| & Other | Adult Cephalic | ||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Superficial) | |||||||||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral | |||||||||||
| vessel | Peripheral vessel | ||||||||||
| Other (Specify***) | |||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B. | |||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | |||||||||||
| **Small organ-breast, thyroid, testes. | |||||||||||
| ***Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||||
| Note 2: Smart3D | |||||||||||
| Note 3:4D(Real-time 3D) | |||||||||||
| Note 4: iScape | |||||||||||
| Note 5: TDI | |||||||||||
| Note 6: Color M | |||||||||||
| Note 7: Biopsy Guidance | |||||||||||
| Note 8: Elastography | |||||||||||
| Note9: Contrast imaging (Contrast agent for Liver) | |||||||||||
| Note 10: Contrast imaging(contrast agent for LVO) | |||||||||||
| Note 11: STE | |||||||||||
| Note 12: STQ | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | |||||||||||
| Prescription USE (Per 21 CFR 801.109) | |||||||||||
| System: | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- | ||||||||||
| 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | |||||||||||
| Transducer: | L14-5WE | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| General (Track | |||||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (specify) | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | |||||||||||
| Abdominal | N | N | N | N | N | N | Note 1,2, 4,7 | ||||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | N | N | N | N | N | N | Note 1,2, 4,7 | ||||
| Small Organ (Specify**) | N | N | N | N | N | N | Note 1,2, 4,7,8,11,12 | ||||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1,2, 4,7 | ||||
| Fetal Imaging | |||||||||||
| & Other | Adult Cephalic | ||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | N | N | N | N | N | N | Note 1,2, 4,7,11,12 | ||||
| Musculo-skeletal | |||||||||||
| (Superficial) | N | N | N | N | N | N | Note 1,2, 4,7,11,12 | ||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral | |||||||||||
| vessel | Peripheral vessel | N | N | N | N | N | N | Note 1,2, 4,7 | |||
| Other (Specify***) | |||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | |||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B. | |||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | |||||||||||
| **Small organ-breast, thyroid, testes. | |||||||||||
| ***Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |||||||||||
| Note 2: Smart3D | |||||||||||
| Note 3:4D(Real-time 3D) | |||||||||||
| Note 4: iScape | |||||||||||
| Note 5: TDI | |||||||||||
| Note 6: Color M | |||||||||||
| Note 7: Biopsy Guidance | |||||||||||
| Note 8: Elastography | |||||||||||
| Note 9: Contrast imaging (Contrast agent for Liver) | |||||||||||
| Note 10: Contrast imaging (Contrast agent for LVO) | |||||||||||
| Note 11: STE | |||||||||||
| Note 12: STQ | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | |||||||||||
| Prescription USE (Per 21 CFR 801.109) | |||||||||||
| System: | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- | ||||||||||
| 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | |||||||||||
| Transducer: | L20-5E | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| General (Track | |||||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (specify) | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify**) | N | N | N | N | N | N | Note 1, 2, 4 | ||||
| Neonatal Cephalic | |||||||||||
| Fetal Imaging | |||||||||||
| & Other | Adult Cephalic | ||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | N | N | N | N | N | N | Note 1, 2, 4, 8 | ||||
| Musculo-skeletal | |||||||||||
| (Superficial) | N | N | N | N | N | N | Note 1. 2. 4. 8 | ||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral vessel | N | N | N | N | N | N | Note 1, 2, 4 | ||||
| Other (Specify***) | |||||||||||
| Peripheral | |||||||||||
| vessel | N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B. | |||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | |||||||||||
| **Small organ-breast, thyroid, testes. | |||||||||||
| ***Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |||||||||||
| Note 2: Smart3D | |||||||||||
| Note 3:4D(Real-time 3D) | |||||||||||
| Note 4: iScape | |||||||||||
| Note 5: TDI | |||||||||||
| Note 6: Color M | |||||||||||
| Note 7: Biopsy Guidance | |||||||||||
| Note 8: Elastography | |||||||||||
| Note 9: Contrast imaging (Contrast agent for Liver) | |||||||||||
| Note 10: Contrast imaging (Contrast agent for LVO) | |||||||||||
| Note 11: STE | |||||||||||
| Note 12: STQ | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | |||||||||||
| Prescription USE (Per 21 CFR 801.109) | |||||||||||
| System: | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- | ||||||||||
| 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | |||||||||||
| Transducer: | SC5-1NE | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| General (Track | Color | Amplitude Combined | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Doppler | Doppler | (specify) | Other (Specify) | ||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | N | N | N | N | N | N | Note 1, 2, 4, 6,7 | ||||
| Abdominal | N | N | N | N | N | N | Note 1, 2, 4,6,7 | ||||
| Intra-operative (Specify*) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify**) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Fetal Imaging | Adult Cephalic | ||||||||||
| & Other | Trans-rectal | ||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | N | N | N | N | N | N | Note 1, 2, 4,6,7 | ||||
| Musculo-skeletal | |||||||||||
| (Superficial) | |||||||||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| vessel | Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA; | E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power+PW+B. | |||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | |||||||||||
| ** Small organ-breast, thyroid, testes. | |||||||||||
| ***Other use includes Urology. | |||||||||||
| Note 1: Tissue Harmonic Imaging. | |||||||||||
| Note 2: Smart3D | |||||||||||
| Note 3:4D(Real-time 3D) | |||||||||||
| Note 4: iScape | |||||||||||
| Note 5: TDI | |||||||||||
| Note 6: Color M | |||||||||||
| Note 7: Biopsy Guidance | |||||||||||
| Note 8: Elastography | |||||||||||
| Note 9: Contrast imaging (Contrast agent for Liver) | |||||||||||
| Note 10: Contrast imaging(contrast agent for LVO) | |||||||||||
| Note 11: STE | |||||||||||
| Note 12: STQ | |||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | |||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | |||||||||||
| Prescription USE (Per 21 CFR 801.109) |
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510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. Submitter:
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Tel: +86 755 8188 5655 Fax: +86 755 2658 2680
Contact Person:
Zhang Wei
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Date Prepared: January 25, 2019
2. Device Name:
DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System Classification Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX) 21 CFR 892.2050 Picture Archiving and Communications System(LLZ)
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3. Device Description:
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A
Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CW mode, Color-mode, Color M-mode, Power/Dirpower mode, TDI mode, THI, iScape, Biopsy Guidance, 3D/4D mode, Elastography, Contrast imaging or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.
4. Intended Use:
The DC-80A /DC-80A Exp/DC-80A DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams.
5. Comparison with Predicate Devices:
DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:
| Predicate Device | Manufacturer | Model | 510(k) Control Number |
|---|---|---|---|
| 1. Primary predicate device | Mindray | DC-70 | K181637 |
| 2. Reference device | Mindray | Resona 7 | K171233 |
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-888/DC-80A/DC-80A
Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System employs the same technology as the predicate devices. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of
18
anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations. The subject device also has the same intended uses and basic operating modes as the predicate devices.
- Subject device DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 has the similar intended uses with the predicated device DC-70(K181637) .
- The materials of probes and Needle-guided brackets of . DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 are the same to the predicate device DC-70(K181637).
- . The acoustic power levels of DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 are below the limits of FDA, which is the same as the predicated device DC-70(K181637).
- DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device DC-70(K181637).
| Predicate
| Device | Model | Items | Specific differences |
|---|---|---|---|
| 1. Primary | |||
| predicate | |||
| device | DC-70 | Differences of | |
| Intended uses | The DC-70 series have more intended | ||
| uses about Trans-esoph. (Cardiac) and | |||
| intra-operative (abdominal, thoracic, and | |||
| vascular). | |||
| But the DC-90 series don't have. | |||
| Differences of | |||
| Transducers | The DC-90 series support one new | ||
| transducer which is SC5-1NE. | |||
| The other transducers that SC6-1E, | |||
| C11-3E, L12-3E, L9-3E, V11-3HE, | |||
| SP5-1E, P7-3E, SD8-1E, L14-5WE, | |||
| L20-5E, DE11-3E were cleared by |
The differences between the DC-90 series and the predicate devices:
19
| DC-70. | |||
|---|---|---|---|
| Hardware | |||
| platform | |||
| improvement | One more transducer port of DC-90 | ||
| series. | |||
| The battery of DC-90 series can provide | |||
| power supply when working. | |||
| The DC-90 series have two hard disks | |||
| (128G SSD+1T HDD) and the DC-70 | |||
| series only have one hard disk (1T HDD). | |||
| The signal channel between the probe and | |||
| the main host is 128. The DC-70 series | |||
| only have 64. | |||
| Differences of | |||
| Software | |||
| Functions | The DC-90 series have new Software | ||
| Functions: STE, STQ, Smart Pelvic and | |||
| Dehaze; | |||
| 2. Reference | |||
| device | Resona | ||
| 7 | New Software | ||
| Functions | The Software Functions about STE, STQ, | ||
| Smart Pelvic were cleared in Resona 7 | |||
| (K171233) |
6. Non-clinical Tests:
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A
Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System has been evaluated for software, cybersecurity testing, acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards.
Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and ■ a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
- . IEC 60601-1-2 Edition 4.0 2014-02, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
- . IEC 60601-2-37 Edition 2.1 2015, medical electrical equipment - part 2-37:
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particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
- IEC 62304 Edition 1.1 2015-06, medical device software software life cycle . processes.
- . ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices.
- NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic . ultrasound equipment revision 3.
- AAMI / ANSI / ISO 10993-1:2009/(R)2013, biological evaluation of medical . devices - part 1: evaluation and testing within a risk management process.
- . IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
- . IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
7. Clinical Tests:
Not Applicable.
8. Conclusion:
Intended uses and other key features are consistent with traditional clinical practices. FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the
DC-90/DC-90S/DC-900/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.